Purpose
The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues. Works with research associates and scientists to establish a reporting database and analyze data for clinical studies.
Primary Responsibilities
Statistical Trial Design and Analysis
- Provide input on study protocols and write protocols for study conduct.
- Select statistical methods for data analysis; author protocol and statistical analysis plan sections; conduct analysis once a reporting database is created.
- Collaborate with data sciences on planning/implementation of data quality assurance plans.
- Stay current with statistical methodology; apply new methods and justify selected methods.
- Perform peer-review of work products from statistical colleagues.
- Influence team members regarding appropriate research methods.
Communication of Results and Inferences
- Collaborate to write reports and communicate results.
- Communicate study results via regulatory submissions, manuscripts, oral presentations, one-on-one customer communications, and scientific meetings.
- Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge
- Understand disease states, competitive landscapes, and regulatory environment.
Regulatory Compliance
- Perform work in compliance with assigned curriculum(s) and applicable policies, procedures, processes, and training.
Statistical leadership and Teamwork
- Introduce innovative methodology/tools to solve critical problems.
- Merge scientific thinking and business knowledge to identify issues and implement solutions.
- Lead projects independently and work effectively across functions; influence business decisions with technical expertise.
Minimum Qualifications
- Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Science; at least 3 years of experience in Real World Evidence research.
Preferred Skills/Additional Preferences
- Proficient in SAS, R, Spotfire, WinBUGs, etc.
- Interpersonal communication, teamwork/leadership.
- Working knowledge of experimental design and statistical analysis.
- Self-management, resource management, creativity/innovation, problem solving, and critical thinking.
Compensation/Benefits
- Anticipated wage: $151,500 - $244,200. Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.